ES2433146T5 - Protective needle tip housing located inside a catheter connector - Google Patents

Description

DESCRIPTION

Protective needle tip housing located inside a catheter connector

This document is generally concerned with needle assemblies of particular interest extending to needle assemblies having a tip protector comprising closed wall surfaces to prevent contact with the needle tip from one side.

BACKGROUND

The insertion procedure for an IV catheter set contains four basic steps: (1) the healthcare worker inserts the needle and catheter together into the patient's vein; (2) after insertion into the vein with the tip of the needle, the catheter is directed into the patient's vein when the healthcare worker pushes the catheter with his finger; (3) the healthcare worker removes the needle by holding the end of the connector (opposite the end of the tip) while at the same time applying pressure with his free hand to the patients skin at the insertion site; and (4) the healthcare worker then tapes the already inserted catheter to the patients' skin and connects the exposed end of the catheter (the catheter connector) to the source of the fluid to be administered vein to the patients.

The problem is that, immediately after removal of the needle from the patients vein, the healthcare worker who is currently involved in at least two urgent procedures must place the exposed needle tip in a nearby location and address the tasks required to get the needle removed. It is at this juncture that the exposed needle tip creates an accidental needle stick hazard, which depending on the circumstances, leaves the healthcare worker vulnerable to the transmission of various dangerous blood borne pathogens, including AIDS and hepatitis.

Other types of needle similarly expose healthcare workers to risks of accidental needle sticks. For example, a doctor who administers an injection, using a straight needle, a Huber needle, an epidural needle, etc., may leave the used needle in a tray for a patient to dispose of later. During the period between placing the used needle on a tray or workstation until it is discarded, the used needle is a potential source of disease transmission for those working near or around the needle. Therefore, all needles should be covered immediately after use to ensure greater worker safety. Ideally, the procedure for covering the needle tip should be passive, self-activating, or at least easy to perform. Furthermore, the device for covering the needle should be reliable and robust.

WO 01/10488 A1 refers to a device for inhibiting unintended contact with the tip of a needle (122) having a cable guide arranged in a lumen thereof. A housing (102) of the device has an interior cavity. A rotating member (110) is located within the cavity, defining a distal opening, and a proximal opening that are sized to allow the needle to pass through the openings. When the needle tip is within the cavity, and the needle is withdrawn from the distal opening of the rotating member, a spring (126) or a compressible member tilts the rotating member toward a locking connection with the needle to prevent further movement of the needle.

US 2004/0236288 A1 relates to a needle guard assembly constructed to securely protect the sharp distal tip of a needle, and restrict distal movement of the needle tip by a tilt plate or "skew" after that the tip has been protected.

WO 99/08742 A1, US 6,117,108 and US 6,616,630 B1, respectively, disclose a safety IV catheter that includes a unitary elastic needle guard received in a catheter connector. The needle guard includes a proximal arm or wall that includes an opening through which the needle passes for axial movement. When the needle retracts from the catheter, it releases the force that has previously prevented movement of the needle guard within the catheter connector. This in turn causes the needle guard to snap into a position where its distal wall blocks access to the needle tip. In this condition, the spring needle guard and the needle can be removed from the catheter connector.

EP 2 000 165 A1 relates to a protector which is mounted on a needle body including an elongated main needle body and an enlarged diameter section provided on a distal side of the main needle body and having an external diameter greater than that of the main needle body. The protector can be moved from a first position capable of moving relatively along a longitudinal direction of the needle body to a second position covering a needle point of the needle body. The protector includes a protector body including a first section formed within the first hole adapted to receive the needle body when the needle body is passed through, a second section formed with a second hole, and a third section adapted to connect the first and second section.

US 2005/0075609 A1 refers to needle guard pliers having multiple gripping arms and deflection forces to block a needle tip of a needle and to secure it over the needle. Examples of needle clips include those that have a connecting arm that has an opening that moves from a radially inward position to a radially outward position when the needle is moved close to the opening. Additional arms can be incorporated with each arm having an opening to allow the needle to project through it. As the needle moves near the first opening of the first connecting arm, the openings in the remaining connecting arms rest against one side of the needle to secure the needle clamp to the needle.

WO 01/93940 A2 discloses a needle assembly according to the preamble of claim 1. US 2005/0096592 A1 relates to a safety guard including a protective device including a piercing member having a proximal end, a distal end that defines a longitudinal axis. The safety shield reduces the occurrence of inadvertent or unwanted punctures from a contaminated piercing member and reduces exposure to pathogens. A clamp defines a first cavity dimensioned for movement of the piercing member therethrough and is oriented on an axis transverse to the longitudinal axis. The first cavity can move between a movable orientation and a bonding orientation. The clamp includes a first temple defining a second cavity sized for movement of the piercing member therethrough and a distal portion that is configured to engage a medical device. The clamp further includes a second temple having a bearing surface that engages the piercing member. The pins are offset for convergent motion so that the first cavity is disposed in the bonding orientation and the distal portion of the first pin is disengaged from the medical device.

US 2005/0080378 A1 discloses a medical needle assembly including a needle cannula having a body and a tip. The tip is disposed at a distal end of the cannula. An elongated member has a first end and a second end. The first end is fixedly fixed to the body of the needle cannula at a connection point and the second end extends radially outward from the body of the needle. A shield is slidably mounted to the needle for movement between a proximal and a distal position. The protector includes a protector body having a central chamber, a distal end and a proximal end, as well as a plate secured to the protector body and defining an opening. When the shield is in the distal position, the second end of the elongate member extends radially outward from the needle body preventing passage of the elongate member through the opening. An element can be secured to the cannula body to restrict movement of the shield relative to the needle.

US 2003/0060771 A1 relates to a catheter and an introducer needle assembly having a needle attached to a needle connector and, an enlarged area disposed thereon, and a tubular catheter into which the introducer needle is received coaxially within the catheter. The assembly includes a needle tip protector disposed within the catheter connector and includes at least one radially extending unrestricted flange disposed distal to the annular rib so as to retain the protector within the connector. The shield has a proximal opening at the proximal end that is unrestricted in size greater than the size of the needle diameter and less than the enlarged area so that when the needle is withdrawn from the catheter the shield remains attached to the needle.

Document US 2005/0182362 A1 discloses a needle guard (1) based on an inclination plate (6) that engages in such a way that it is blocked with the needle shaft (2) both after retraction of the needle tip inside the protector (1), as after any attempt to cause the needle tip to re-emerge from the protector (1). SUMMARY

The invention comprises a needle assembly, as defined in claim 1.

In accordance with aspects of the present invention, a needle guard is provided that blocks the needle tip from direct contact with a needle tip.

More preferably, the tip protector incorporates side walls to provide protection to the tip of the needle from view and exposure to blood dripping from within the tip of the needle.

In a further aspect of the present invention, a baffle plate is provided to deflect the needle and not inadvertently re-emerge from within the tip guard.

In yet another aspect of the present invention, the baffle plate is used, at least in part, to locate the tip guard within a housing.

Another object of the present invention is to incorporate the tip protector into a safety IV catheter to automatically protect a needle tip when withdrawing a needle from a catheter tube by an elastic connection between the tip protector and the catheter connector. The elastic connection allows a relatively smoother release without having to reduce typical manufacturing tolerances.

Further disclosed is a tip protector for locking a needle tip comprising: a tip protector housing located within a connector having an inner surface; passing a needle through the tip protector and housing; a first arm extending from a distal wall from the deflected tip protective housing against the inner surface; a second arm extending from a proximal wall of the deflected tip protective housing against the inner surface; and a third arm extending from the proximal wall of the tip guard housing and deflected against one side of the needle.

In addition, a tip protector is disclosed for mounting on a needle to protect a needle tip comprising: a first protector body comprising a proximal wall and an arm extending distally from the proximal wall; Said arm further comprises: a distal wall at one end of the arm to block a needle point; an uneven arm width to accommodate a needle extending from the proximal wall and the distal wall; a second protective body attached to the first protective body, the second protective body comprising a distal wall and two side walls defining a cavity to accommodate the first protective body; and a baffle plate comprising a projection that projects into the cavity, the projection and the distal wall at the end of the arm are configured to limit the movement of a needle point to move distally from the distal wall of the second protective body.

In addition, a tip protector is provided for mounting on a needle to protect a needle tip comprising: a first protector body attached to a second protector body; the first protective body comprising a proximal wall and an arm, comprising a distal end portion of the arm, extending distally from the proximal wall; the second protective body comprising two side walls and two end walls defining a cavity to accommodate the first protective body; the two side walls each comprise a first edge and a second edge; a baffle plate comprising a projection projecting into the cavity, the baffle plate is configured to deviate and move relative to the first edge and the second edge; and wherein the projection and distal end ratio of the arm are configured to be on different sides of a needle axis defined by a center line when the tip guard is mounted on a needle and the tip guard in a ready position. for your use.

In addition, a needle assembly is provided comprising: a housing comprising a wall having an interior wall surface defining a cavity having a tip protector disposed therein; a needle, having an axis having a first side and a second side defined by a center line and a needle point, which passes through the housing and the tip guard; the tip protector comprising a distal wall, two side walls, a proximal wall, a first arm extending from the proximal wall to the distal wall, a second arm that is shorter than the first arm, extending from the proximal wall, and a wall opposite the second arm; and wherein the wall opposite the second arm and the second arm are both offset against the surface of the interior wall of the housing.

Other aspects and features of the tip protectors provided herein will be better appreciated as they are better understood with reference to the specification, claims and accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The attached drawings include:

FIGURES 1A and 1B are semi-schematic partial cross-sectional views of a prior art safety IV catheter incorporating a tip protector comprising an upper wall and two side walls;

FIGURE 2 is a semi-schematic perspective view of a tip protector provided in accordance with the present invention comprising a first protector body and a second protector body for locking a needle tip;

FIGURE 3 is a top view of the tip protector of FIGURE 2;

FIGURE 4 is a bottom view of the tip protector of FIGURE 2;

FIGURE 5 is a semi-schematic cross-sectional side view of the clamp of FIGURE 4 taken along line 5-5;

FIGURE 6 is a semi-schematic end view of the clamp of FIGURE 5 taken along line 6-6; FIGURE 7 is a semi-schematic front view of the caliper of FIGURE 5 taken along line 7 7;

FIGURE 8 is a semi-schematic cross-sectional side view of the first protective body of FIGURE 2 shown without the second protective body;

FIGURE 9 is a semi-schematic cross-sectional end view of an arm of the first protective body of FIGURE 8 taken along line 9-9;

FIGURE 10 is a semi-schematic end view of the first protective body of FIGURE 8 taken along line 10-10;

FIGURE 11 is a semi-schematic cross sectional side view of a catheter assembly incorporating the tip protector of FIGURE 2 shown in a ready-to-use position;

FIGURE 12 is a final cross-sectional view of the catheter assembly of FIGURE 11 taken along line 12-12;

FIGURE 13 is a partial cross-sectional side view of the catheter assembly of FIGURE 11 shown with the needle connector retracted from the catheter tube and the tip guard blocking the needle tip, in a used position;

FIGURE 14 is a partial cross-sectional side view of the needle connector completely removed from the catheter connector with the protector of FIGURE 2 remaining on the needle to block the tip of the needle; Y

FIGURE 15 is a semi-schematic perspective view of a second alternative protective body provided in accordance with the present invention.

DETAILED DESCRIPTION

The detailed description set forth below in connection with the accompanying drawings is intended to be a description of the presently preferred embodiments of a tip protector for use on a number of needles or needle assemblies provided in accordance with the present invention. The description sets forth the features and steps for the construction and use of the tip protector of the present invention in relation to the illustrated embodiments. However, it should be understood that the same or equivalent functions and structures can be obtained by different embodiments also intended to be included within the scope of the invention. As denoted at any point in this document, similar item numbers are intended to indicate the same or similar items or characteristics.

Figures 1A and 1B illustrate a prior art spring clamp needle guard shown and described in United States Patent No. 6,616,630 to Woehr et al. For cross reference purposes, Figures 1A and 1B shown herein are labeled and discussed in the '630 patent as Figures 4A and 4B. As shown in that document and previously reproduced as Figures 1A and 1B, the spring clamp needle guard 40a includes a distal arm 65 terminating at its upper end in a curved flange 66 and at its lower end in a portion U-shaped 67 which, in the ready-to-use position illustrated in FIGURE 1A, contacts a bulge 68 formed in the lower inner wall of catheter connector 26.

A transverse segment 69 having a central opening 70 extends proximally and upward and terminates in a U-shaped upper portion 72. As disclosed in the '630 patent, the opening is configured to hold the needle in a used position, at points d and e, which have been added. A proximal end wall 74 having an opening 76 extends vertically from portion 72 and then extends distally into a horizontal lower segment 78, having an opening 80 through which the lower halves of the distal arm 65 and the segment Cross 69 extend into the ready position for use of the needle guard. Segment 78, at its distal end, extends upward into a front wall 82 having a central opening 84 axially aligned with openings 70, 76. At its upper end, distal front wall 82 extends in the proximal direction in an upper segment 86, which, as shown in FIGURE 1A, contacts the upper inner wall of the catheter connector substantially along its entire length.

When the catheter is in the ready-for-use position, the needle shaft passes through openings 70, 76, and 84 and rests on curved flange 66, which drives arm 65 against bulge 68 on the bottom wall of the catheter connector. This connection, together with the elastic connection of the upper segment 86 with the upper inner wall of the catheter connector, retains the spring clamp 40a in its ready-for-use position within the catheter connector. When needle connector 12 and needle 16 retract to the right, as seen in FIGURE 1A, in a sufficient amount, the tip of needle 18 moves proximal to flange 66 and eventually passes under flange 66 When this occurs, the downward force on arm 65 is released thereby allowing arm 65 to snap upward to the retracted position illustrated in FIGURE 4B, where arm 65 and flange 66 extend on the needle tip 18 to thereby avoid accidental contact with the needle tip. In this condition, the needle guard 40a is held on the axis of the needle 16 at points d and e of the opening 70 and the needle and needle guard attached thereto can be easily removed from the catheter connector.

Although the prior art tip protector 40a shown in Figures 1A and 1B is well designed for its intended purpose, there are still a number of improvements that could be made to the tip protector 40a to make it more reliable, effective and easy to manufacture.

Now referring to FIGURE 2, a tip protector provided in accordance with the present invention is shown, which is generally designated by the number 100. In one embodiment, the tip protector 100 comprises a first protector body (see, also FIGURE 5) 102 surrounded, at least in part, by a second protective body 104.

In one embodiment, the second protective body 104 comprises a distal wall 106 comprising an opening 108, which preferably has a circular configuration. A plurality of walls extend distally from distal wall 106, which includes two side walls 110A, 110B, and a baffle wall, plate, or arm 112. The second shield body 104 is preferably formed from a single stamped stainless steel sheet or cut out that looks like a "T", which has a circular recess 108 at the intersection of the three branches of the "T" to form the opening 108 in the distal wall 106. In an embodiment, the intersection of the shaped plate of T is pressed against a metallic shape or die, such as carbide, which then forms the curvilinear perimeter contour 114 around the perimeter of the distal wall 106 while simultaneously pushing the two side walls 110A, 110B and the deflector plate 112 proximally . A lower perimeter outline can also be formed by this process.

In one embodiment, the edges 116 of the two side walls 110A, 110B and the baffle plate 112 are formed by fitting into the same die used to form the curvilinear perimeter contour 114 of the distal wall 106. In this way, the intersections 118 between the two side walls 110A, 110B and the baffle plate 112 are generally curved or smooth rather than at right angles (also shown in Figures 6 and 7). As discussed further below, the soft edges 116 allow the tip guard 100 to come in contact with an inner surface of a clamp housing or catheter connector over a larger surface area compared to corners that have a right angle simple, which would result in a single point contact. The side walls and baffle plate are preferably close enough together to protect the needle tip from view and collect any drops of blood that may drip from the needle while it is inside the needle tip.

In an exemplary embodiment, a projection or recess 120 is incorporated into the baffle plate 112 to limit movement of the needle in an activated position, as also discussed below. The width of the sunken section 120, which extends from one side wall 110A to another side wall 110B, is slightly less than the width of the deflector plate immediately proximal and distal to the sunken section. The disparate widths along the baffle plate 112 allow the recess 120 to form after forming the soft corners 116. However, the tip guard 100 can incorporate right-angle corners at the various intersections 118 and in the baffle plate 112 having a uniform width, which are less preferred, without departing from the spirit and scope of the present invention. An optional opening 122 can be incorporated into baffle plate 112 for ease of mounting. For example, a bolt (not shown) could be inserted through opening 122 to push arm 140 (FIGURE 5) of the first protective body down. This could assist in the assembly of the posterior end of a cannula or needle through the protector. Preferably, the opening is not necessary since the distal wall 150 of the first protective body 102 is angled thereby allowing the posterior end of the cannula to simply deflect the distal wall downward for automatic mounting.

FIGURE 3 is a top view of the tip guard 100 of FIGURE 2. In one embodiment, a reduced proximal section 124 is incorporated into the baffle plate 112, which has a width dimension less than the immediately distal section. A gap 126 is created on each side of the reduced proximal section 124, which is in part defined by each side wall 110A, 110B and the reduced proximal portion 124. The two gaps 126, however, can be filled while maintaining the same width throughout the length of the baffle plate 112.

In an exemplary embodiment, a mounting plate is incorporated into the side wall 128A, 128B at a proximal end of each side wall 110A, 110B. If a center line or axis is drawn longitudinally with respect to the tip guard 100, the two side wall fixing plates 128a, 128B are orthogonal to the axis and are generally coplanar. However, the two fixing plates 128A, 128B may overlap and may not be coplanar without departing from the spirit and scope of the present invention. As also discussed below, the two fixing plates 128A, 128B are means by which the second protective body 104 is attached to the first protective body 102.

FIGURE 4 is a bottom view of the tip protector 100 of FIGURE 2. The first protector body 102 is clearly shown located between the two side walls 110A, 110B of the second protector body 104. In an exemplary embodiment, an arm is incorporated 130 to stabilize protector 100 within a housing or connector. Arm 130 extends distally from a proximal wall 132 (see also FIGURE 5) and includes an elbow or vertex 133 defined by an upstream section 134 positioned at an angle to a downstream section 136 (see also FIGURE 5) . As also discussed below, arm 130 is configured to rotate, flex, or cantilever around a point 138 at a proximal end of tip guard 100, which acts as a hinge. Proximal wall 132 and the two fixation plates 128A, 128B together define a protective proximal end 129.

An arm 140 of relatively greater length than arm 130 to stabilize, to block a needle point also extends from proximal wall 132. In one embodiment, arm 140 comprises an opening 142 and two ribs 144. Preferably, the Aperture 142 has an elongated shape and ribs 144 are formed by a wedging process. Arm 140 further includes a forearm section 146, a return section 148 (FIGURE 5), a distal wall 150 (FIGURE 5) to block a needle point, and a terminal or finger section 152 (FIGURE 5) to overlap a portion of the needle in the used position. Together, the forearm section 146, the return section 148, the distal wall 150, and the finger 152 are collectively referred to herein as distal arm locking selection. In an exemplary embodiment, the arm section with opening 142 is wider than the remaining arm sections. This configuration results in not only the incorporation of opening 142 but also two wedged ribs 144. Alternatively, a tab or flange may be incorporated into each edge of the arm section and then bent to form two ribs. The reciprocating arm, without the wedged ribs, can have a uniform width therethrough.

FIGURE 5 is a cross-sectional side view of the tip protector of FIGURE 4 taken along line 5-5. Arms 130, 140 can be seen extending from two different edges of proximal wall 132. As shown in FIGURE 11, when tip guard 100 is positioned over a needle, the two arms originate from the opposite side of the needle, seen from a center line of the needle. However, the longest arm 140 extends distally from proximal wall 132 at an angle and cuts the axis of the needle, with the needle passing through opening 142 in the arm. The short arm 130, however, does not touch or intersect the needle. More preferably, the terminal edge 154 of the short arm 130 is separated from the needle, both in a ready-to-use position and in a used position.

As also discussed below, when tip guard 100 is in a ready-to-use position, long arm 140 is offset biased radially outward toward short arm 130 and finger 152 is in contact with one side of the needle. To do this, long arm 140 flexes, at least in part, around a point 156 on proximal wall 132 when it is abutting in contact with one side of the needle.

Referring again to FIGURE 3 in combination with FIGURE 5, the baffle plate 112 is cantilevered from the perimeter contour 114 of the distal wall 106 of the second shield body 104. This allows the entire baffle plate 112 and more specifically the reduced proximal portion 124, deviates like a springboard. In one embodiment, the dimension between the vertex 133 of the short arm 130 and the rounded edges 116 of the deflector plate 112 should be greater than the internal curvature of a housing to the tip protector where it is to be placed, so that both the baffle plate 112 and the short arm 130 are deflected inward by the wall surface of the housing. In other words, when the tip protector 100 is mounted inside a housing, such as the catheter connector shown in FIGURE 11, the tip protector is squeezed at the two rounded edges on the baffle plate 112 and the short arm 130. This squeezing action allows the tip protector to be removably secured to the housing or connector.

FIGURE 6 is a final view of the tip protector of Figure 5 taken along line 6-6. The two lateral clamping plates 128A, 128 ^b are shown in contact with the proximally facing surface of proximal wall 132. In one embodiment, the two clamping plates 128A, 128B are welded, using ultrasound, high-frequency welding, or laser to proximal wall 130. An opening 158 is incorporated into proximal wall 130 of first protective body 102 to receive a needle (not shown). The two fixation walls 128A, 128B both incorporate recesses 160 that look like two semicircles, which together have a diameter greater than the opening 158 in the proximal wall 130. Alternatively, the two fixation walls 128A, 128B can overlap each other and each incorporates a different opening having a diameter greater than the diameter in opening 158 of the proximal wall.

FIGURE 7 is a front view of the tip guard 100 of FIGURE 5 taken along line 7-7. As clearly shown, the second protective body 104 incorporates a plurality of wall structures, specifically on the two side walls 110A, 110B and the baffle plate 112, a front wall 106 and two fixing walls 128A, 128B (not shown) to form an enclosure comprising a cavity 155 and a central access opening 162 (See also FIGURE 5). Referring to Figures 5 and 6 in addition to FIGURE 7, short arm 130 projects outward through central access opening 162 to provide a point of contact between the tip guard and a housing, such as a connector catheter. Long arm 140 (FIGURE 5) similarly projects outward through central access opening 162 when in a ready-to-use position but moves into cavity 155 when in a used position, as also discussed later.

FIGURE 8 is a cross-sectional side view of the first protective body 102 of FIGURE 1, shown without the second protective body 104. In one embodiment, the first protective body 102 is formed from a single stainless steel sheet. integral. The opening 142 could be stamped and the two ribs 144 wedged before the first protective body 102 is formed in the shape shown in FIGURE 8.

FIGURE 9 is a final cross-sectional view of the first protective body 102 of FIGURE 8 taken along line 9-9. Part of the two ribs 144, opening 142 between the two ribs, and proximal wall 132 are shown.

FIGURE 10 is a final sectional view of the first body 102 of FIGURE 8 taken along line 10-10. Part of the elongated opening 142 and the distal wall 150 can be seen through the opening 158 in the proximal wall 132. In one embodiment, four recesses 164 are formed in each corner of the proximal wall 132. The recesses 164 are configured to reduce the amount of spring force generated by the two arms 130 and 140. The amount of recess can be varied to obtain a desired spring force.

Referring again to FIGURE 5, the tip protector disclosed in this document may be viewed as a device having a housing with three movable arms 112, 130 and 140. The tip protector may also be seen to be provided with a housing with a plate baffle or arm with a tip guard arranged therein having an arm to lock a needle tip and an arm, together with the baffle plate, to elastically secure the tip guard to a connector or clamp housing.

FIGURE 11 is a semi-schematic cross-sectional side view of a catheter assembly 166 incorporating the tip guard 100 of FIGURE 2-10. Generally speaking, catheter assembly 168 comprises a needle connector comprising a needle 170 attached thereto. Needle 170 comprises a sharp needle tip 172, a non-uniform needle section 175 (FIGURE 13) and projects through tip guard 100, catheter connector 174 and catheter tube 176. The needle section does not Uniform 175 may be a fold, an accumulated material, an elbow, or a combination thereof. In a preferred embodiment, the needle connector 168 incorporates a tip section 178 projecting onto the surface of the inner face 180 of the catheter connector 174. The tip section 178 is configured to push the protective proximal end 129 of the Tip 100 to a desired depth or length within cavity 182 defined by wall surface 180 of catheter connector 174 in the ready-to-use position (FIGURE 11).

In an exemplary embodiment, cavity 182 includes a recessed section 184, which may extend across the entire internal circumference of the cavity along a band or width or partial circumference, as shown. The recessed section 184 provides added space for the distal end of the first body section 102 to reduce the amount of compression or deflection force of the finger section 152 and the return section 148. This in turn reduces drag between the finger section 152 and needle side 170 during relative movement between the needle and tip guard 100. Obviously, needle assembly 166 can be practically made without recessed section 184, but is not a preferred shape.

As shown, the recessed section 184 comprises a proximal tapered section 186 and a distal tapered section. Referring to FIGURE 5 in addition to FIGURE 11, the forearm section 146, the return section 148, and the distal wall 150 of the first body section 102 are all located distally and spaced from the proximal tapered section 186. The configuration Separate is incorporated as physical contact between the proximal tapered section 186 and the distal arm locking section need not maintain a fixed relationship between catheter connector 174 and tip guard 100 during movement of needle connector 168 with respect to to the catheter connector. However, the contact between the two can be incorporated without departing from the spirit and scope of the present invention.

Referring now to FIGURE 12 is a final cross-sectional view of the catheter assembly of FIGURE 11 taken along line 12-12, the tip guard 100 is shown in contact with the interior wall surface 180 of the catheter connector 174 at the two edged edges 116 on the baffle plate 112 and two edges of the short arm 130, in the general area of vertex 133. The four contact points are shown in FIGURE 12 with four contact arrows. Thus, in one exemplary embodiment, one arm 130 is cantilevered from a proximal end of the first guard body 102 and another arm 112 is cantilevered from a distal end of the second guard body 104 to retain the tip guard 100. inside a catheter connector. Stated differently, there is provided herein a tip guard having one arm cantilevered from a proximal wall of a protective housing and a second arm cantilevered from a distal wall of the same protective housing. In an alternative embodiment, the cantilever arm 112 is removed and the two side walls 110A, 110 ^b together with the short arm 130 are configured to removably secure the alternative tip protector to a housing, such as a catheter connector or a clamp housing.

FIGURE 13 is a partial cross-sectional side view of catheter assembly 166 of FIGURE 11, shown in a used position, with needle 170 retracted to the right of FIGURE 11. Tip protector 100, and thus the Needle 170, is moved to the used position shown in FIGURE 13 holding catheter connector 174 in one hand while removing needle connector 168 to the right of FIGURE 11 (or vice versa, i.e. holding needle connector 168 and while moving catheter connector 174 to the left of FIGURE 11). As the tip of the needle 172 moves proximally with respect to the finger section 152, the deviation force acting on the arm 140 is withdrawn thereby allowing the arm to regain its less flexed state, which is shown in FIGURE 13. As needle connector 168 continues to move to the right, non-uniform section 175 in needle 170, which has a cross-sectional dimension larger than opening 158 in proximal wall 132 of the first body protector 102, contacts opening 168 and pulls the proximal wall, through connection with the perimeter of opening 168, to the right. If the pulling force on the proximal wall 132 is greater than the friction force between the cantilever arm 112, the short arm 130, and the inner surface 180 of the catheter connector, the friction is overcome and the tip guard 100 is removed. unhook the catheter connector.

FIGURE 14 shows tip guard 100 removed from catheter connector 174 and distal wall 150 blocking the tip of the needle. Since the tip protector incorporates two side walls 110A, 110B, and a baffle plate 112, the tip protector covers approximately three-fourths of the circumference of the needle 170 near the tip of the needle. The remaining section of needle 170 near the tip of needle 172 is also partially covered by short arm 130 and the distal locking section of first protective body 102. The tip of the needle is protected from sight or contact. The blood, which can drip from the tip of the needle, is configured to be collected by one of the walls.

As shown in FIGURE 14, if a force is exerted on the distal end of the tip guard near the At point 189, needle 170 could rotate away from the protection provided by finger section 152 and be manipulated such that it re-emerges out of opening 108 of distal wall 106 of second protector body 104. Accordingly, in an example of In one embodiment, the sinking or projection 120 of the baffle plate 112 is configured to inhibit or limit the movement of the needle in the event of a direct or incidental force on the tip guard at or near the tip 189. The projection 120 is configured to prevent movement of needle tip 172 radially to finger section 152.

FIGURE 15 is a semi-schematic perspective view of a second protective body 188 provided in accordance with aspects of the present invention. The second alternate guard body 188 may cooperate with the first guard body shown in Figures 8-10 to form an alternate tip guard. In an embodiment, the second alternative protective body 188 incorporates a baffle plate 190 comprising a generally curvilinear outer surface, a tongue 192 formed by recessing 194 in the baffle plate and including two raised points 196. The tongue 192, as the projection or recess 120 in the second pre-guard body is configured to prevent the tip from rotating outward from the internal space of the tip guard. In an exemplary embodiment, the baffle plate 190 is integrally formed with the side walls 110A and 110B. This can be done, for example, using a deep drawing formation process. Still alternatively, the two side walls 110A, 110B and the baffle plate 190 may have a cutout notch between them.

In an exemplary embodiment, at least a portion of the curvilinear outer surface of baffle plate 190 is configured to contact the inner surface of the catheter connector when it is positioned therein as part of the catheter assembly. As an alternative, the baffle plate 190 incorporates a flat surface such that only the two side edges 198 with the two side walls 110A, 110B contact the inner surface of the catheter connector or clamp housing.

Although limited embodiments of the tip guard and needle devices incorporating the tip guard have been specifically described or illustrated herein, many modifications and variations will be apparent to those skilled in the art. For example, the tip protector described in that document can be used in combination with a cuff or a needle that has an elbow, such as that shown in US Patent No. 6,585,704 to Luther et al. As an alternative, the tip protector described in this document can be used with an outer casing on a needle for use as a syringe, as shown in US Patent No. 6,595,955 to Fergusson et al. Still alternatively, the tip protector described in this document can be used with a grip piece to slide the tip protector along a needle, as shown in document Serial No. 10 / 856,315, entitled PROTeCt IVE DEVICE FOR AN INJECTION NEEDLE. Accordingly, it should be understood that the tip protector and its components, constructed in accordance with the principles of this invention, may be made in a manner different from that specifically described herein. The present description further includes the following aspects.

Aspect 1: A tip protector for locking a needle tip comprising: a tip protector housing located within a connector having an inner surface; passing a needle through the tip protector and housing; a first arm extending from a distal wall of the deflected tip protective housing against the inner surface; a second arm extending from a proximal wall of the deflected tip protective housing against the inner surface; and a third arm extending from the proximal wall of the tip guard housing and deflected against one side of the needle.

Aspect 2: The tip protector according to aspect 1, in which the tip protector housing further comprises two fixing plates fixed to the proximal wall.

Aspect 3: The tip protector according to aspect 1, in which the third arm comprises an opening. Aspect 4: The tip protector according to aspect 3, in which the needle passes through the opening.

Aspect 5: The tip protector according to aspect 1, in which the first arm comprises two edged edges and the two edged edges contact the inner surface.

Aspect 6: The tip protector according to aspect 1, in which the distal wall comprises an opening and the proximal wall comprises an opening and in which the needle passes through both openings.

Aspect 7: A needle mount tip protector for protecting a needle tip comprising: a first protector body comprising a proximal wall and an arm extending distally from the proximal wall; Said arm further comprises: a distal wall at one end of the arm to block a needle point; an uneven arm width to accommodate a needle extending from the proximal wall and the distal wall; a second protective body attached to the first protective body, the second protective body comprising a distal wall and two side walls defining a cavity to accommodate the first protective body; and a baffle plate comprising a projection that projects into the cavity, the projection, and the distal wall at the end of the arm are configured to limit movement of a needle point so that it does not move distally with respect to the distal wall. of the second protective body.

Aspect 8: The tip protector according to aspect 7, further comprising at least one rib on the arm.

Aspect 9: The tip protector according to aspect 7, further comprising a finger located at the end of the distal wall.

Aspect 10: The tip protector according to aspect 7, further comprising a second arm, which is shorter than the arm.

Aspect 11: The tip protector according to aspect 7, wherein the arm comprises an opening.

Aspect 12: A needle mount tip protector for protecting a needle tip comprising: a first protector body attached to a second protector body; the first protective body comprising a proximal wall and an arm, comprising a distal end portion of the arm, extending distally from the proximal wall; the second protective body comprising two side walls and two end walls defining a cavity to accommodate the first protective body; the two side walls each comprise a first edge and a second edge; a baffle plate comprising a projection projecting into the cavity, the baffle plate is configured to deviate and move with respect to the first edge and the second edge; and wherein the projection and the distal end portion of the arm are configured to be on different sides of a needle axis defined by a center line when the tip protector is mounted on a needle and the tip protector is in one position. ready for use.

Aspect 13: The tip protector according to aspect 12, further comprising a rib formed by a wedging process.

Aspect 14: The tip protector according to aspect 12, further comprising a localized opening in the arm.

Aspect 15: The tip protector according to aspect 12, further comprising a second arm extending from the proximal wall of the first protector body.

Aspect 16: The tip protector according to aspect 12, wherein the tip protector is arranged, at least in part, within a connector.

Aspect 17: The tip protector according to aspect 12, in which one of the two edges is edged. Aspect 18: A needle assembly comprising: a housing comprising a wall having an interior wall surface defining a cavity having a tip protector disposed therein; a needle, having an axis having a first side and a second side defined by a center line and a needle point, which passes through the housing and the tip guard; the tip protector comprising a distal wall, two side walls, a proximal wall, a first arm extending from the proximal wall to the distal wall, a second arm that is shorter than the first arm, extending from the proximal wall, and a wall opposite the second arm; and wherein the wall opposite the second arm and the second arm are both offset against the surface of the interior wall of the housing.

Aspect 19: The needle assembly according to aspect 18, wherein the second arm and the wall opposite the second arm are elastically connected to the interior wall surface of the housing.

Aspect 20: The needle assembly according to aspect 18, wherein the two side walls, the second arm, and the wall opposite the second arm are in contact with the surface of the inner wall of the housing. Aspect 21: The needle assembly according to aspect 18, wherein the wall opposite the second arm comprises a projection.

Aspect 22: The needle assembly according to aspect 18, wherein the housing is a catheter connector. Aspect 23: The needle assembly according to aspect 18, wherein the first arm comprises a non-uniform arm width.

Aspect 24: The tip protector according to aspect 1, in which the third arm is located in a first protector body and the first arm and the second arm are located in a second protector body.

Aspect 25: The tip protector according to aspect 24, in which the first protector body is attached to the second protector body.

Aspect 26: The tip protector according to aspect 1, wherein the tip protector is arranged, at least in part, within a connector.

The invention is defined only in the following claims.

Claims (17)

1. A needle assembly comprising: a housing comprising a wall having an interior wall surface (180) defining a cavity having a tip protector (100) disposed therein; a needle (170) that has an axis, a needle point (172) and a non-uniform section (175); passing the needle (170) through the housing and the tip protector (100); including tip protector (100) a proximal wall (132) with an opening (158), with the needle passing through said opening, an arm (140) extending distally from the proximal wall (132); said arm (140) further comprising a distal wall (150) with a terminal section or finger (152) to lock the needle tip (172); a first and a second edge (116); a baffle plate (112) that is configured to deviate and move with respect to the first and second edges (116), the deflector plate (112) comprising a projection (120) projecting into a cavity (155); wherein the non-uniform section (175) in the needle (170) has a larger cross section dimension than the opening (158) and is configured to mate with the opening (158) in the proximal wall (132) in a used position; wherein the non-uniform section (175) is a fold, an accumulated material, an elbow, or combinations thereof; wherein the housing is a catheter connector (174), wherein the tip protector (100) further comprises a second arm (130) extending distally with respect to the proximal arm (132) and configured to stabilize the tip protector (100) within the catheter connector (174 ); Y wherein the second arm (130) is opposite the baffle plate (112); characterized by that in a ready-to-use position of the tip protector (100), said arm (140) is deflected radially outwardly towards said second arm (130), said terminal section or finger (152) of said arm (140) is in contact with one side of the needle (170), and said arm (140) is flexed, at least in part, around a point (156) in the proximal wall (132) when it is abutting in contact with the side of the needle ( 170), the terminal section or finger (152) of said arm (140) overlaps a portion of the needle (170) in the used position, and wherein said baffle plate (112) and said second arm (130) are both offset against the interior wall surface (180) of the catheter connector (174) so that the tip protector is removably secured to the catheter connector (174). 2. The needle assembly according to claim 1, wherein the needle axis (170) has a first side and a second side defined by a center line. 3. The needle assembly according to any of the preceding claims, wherein the arm (140) comprises a non-uniform arm width. The needle assembly according to any of the preceding claims, wherein the arm (140) comprises the distal wall (150) at one end of said arm (140). 5. The needle assembly according to any of the preceding claims, wherein the arm (140) comprises a finger (152). 6. The needle assembly according to any of the preceding claims, wherein the tip guard (100) comprises two side walls (110A, 110B). 7. The needle assembly according to any one of claims 1 to 6, wherein the baffle plate (112) is integrally formed with the side walls (110A, 110B). 8. The needle assembly according to any of the preceding claims, wherein the tip protector (100) comprises two end walls (128A, 128B). 9. The needle assembly according to claim 8, wherein the two end walls (128A, 128B) comprise a recess (160) therebetween. The needle assembly according to claim 9, wherein the two end walls (128A, 128B) comprising the recess (160) are in contact with a proximally facing surface of the proximal wall (132) comprising an opening ( 158) of the tip protector (100). 11. The needle assembly according to any one of claims 8 to 10, wherein the tip protector (100) has an axis and the two end walls (128A, 128B) are located orthogonal to the axis. 12. The needle assembly according to claim 11, wherein the two end walls (128A, 128B) are generally coplanar. 13. The needle assembly according to any one of claims 6 to 12, wherein the two side walls (110A, 110B) of the tip protector (100) each comprise a first and a second edge (116). 14. The needle assembly according to any of the preceding claims, wherein the first and second edges (116) are smooth or a simple right angle. 15. The needle assembly according to any of the preceding claims, wherein the tip guard (100) comprises a distal opening (108) and / or an opening (122, 162). 16. The needle assembly according to claim 15, wherein the distal opening (108) is circular. 17. The needle assembly according to any of the preceding claims, wherein the baffle plate (112) has a uniform width.